819 F. Supp. 2d 1254
S.D. Ala.2011Background
- Plaintiff Ashley Barnhill was prescribed cephalexin (Keflex) for strep throat; prescription filled with Teva-made generic cephalexin under ANDA 62-702.
- Plaintiff took cephalexin in January–February 1998 and later admitted to ingesting leftover pills in March 1998; no prior verified Keflex use.
- Plaintiff developed Stevens–Johnson syndrome (SJS) in March 1998 and was treated at USA Children’s and Women’s Hospital through April 1998.
- Warnings and literature at the time listed SJS as a potential adverse reaction; FDA labeling controls apply to both brand and generic products, with generics’ labels required to match the reference drug.
- This diversity case against Teva USA asserted negligent failure to warn, negligent failure to conduct post-marketing surveillance, and breach of implied warranty of merchantability; other claims were dismissed or conceded.
- The court granted Teva’s summary judgment motion, ruling that the state-law claims were not viable under Alabama law and/or not supported by the record.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption of state-law claims | Plaintiff contends FDA regulations do not preempt state claims against generics. | Defendant argues FDA preemption bars state-law warnings claims for generics. | FDA preemption does not bar the plaintiff's state-law claims. |
| Negligent failure to warn | Warning labeling inadequately warned of SJS risk; placement of risk under Adverse Reactions is insufficient. | Warning was adequate and physician relied on it; no proximate causation shown. | Plaintiff failed to prove proximate causation; warning adequate and not shown to have changed physician decision. |
| Proximate causation under learned intermediary doctrine | Failure to warn causally affected Jaalouk’s prescribing behavior. | No evidence that a stronger warning would have altered prescriber decisions. | No triable issue on proximate causation; no read-and-heed presumption established under Alabama law. |
| Negligent failure to conduct post-marketing surveillance | Teva had a duty to monitor adverse events beyond FDA reporting. | No legal duty identified to monitor events beyond regulatory reporting; no duty shown. | No duty established; no basis for negligence. |
| Breach of implied warranty of merchantability | Cephalexin has non-merchantable risks; Griggs v. Combe allows implied warranty claim. | As an inherently dangerous product, prevails against merchantability claims; Griggs limited. | Implied warranty claim fails; product presumed merchantable and evidence insufficient. |
Key Cases Cited
- Prill v. Marrone, 23 So.3d 1 (Ala. 2009) (elements of negligence: duty, breach, causation, injury)
- Stone v. Smith, Kline & French Lab., 447 So.2d 1301 (Ala.1984) (learned intermediary doctrine in prescription drugs)
- Brasher v. Sandoz Pharma. Corp., 160 F.Supp.2d 1291 (M.D.Ala.2001) (causation in failure-to-warn cases tied to warning adequacy)
- Bodie v. Purdue Pharma. Co., 236 Fed.Appx. 511 (11th Cir.2007) (implied warranty and merchantability for inherently dangerous products)
- Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806 (5th Cir.1992) (read-and-heed presumption limitations in warnings cases)
- Deere & Co. v. Grose, 586 So.2d 196 (Ala.1991) (substantial evidence required to show adequate warning would have prevented injury)
- Gurley v. American Honda Motor Co., 505 So.2d 358 (Ala.1987) (proximate cause framework in warning cases)
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (principal case on FDA preemption of failure-to-warn claims)
- Gaeta v. Perrigo Pharma. Co., 630 F.3d 1225 (9th Cir.2011) (FDA preemption not applying to generic failure-to-warn claims)
- Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir.2010) (preemption in generic drug labeling cases)
- Mensing v. Wyeth, 588 F.3d 603 (5th Cir.2009) (preemption-related discussion in generic context)